In March 2021, the Australian Department of Health published the Therapeutic Goods Order (TGO) 106. It states that from January 2023 on certain medicines need to be serialized and equipped with a DataMatrix in the GS1 standard, including GTIN. Australia is thus taking a further step towards general serialization and will gradually launch a more comprehensive track-and-trace system.
Title: Therapeutic Goods (Medicines-Standard for Serialization and Data Matrix Codes) (TGO 106) Order 2021.
Competent authority: Australian Government – Department of Health – Therapeutic Goods Administration (TGA).
Products: Medicines covered by TGO 106
Code type: GS1-2D DataMatrix with Global Trade Item Number (GTIN).
Timeframe: Serialization since Jan. 01, 2023
The code for pharma serialization in Australia is based on the GS1 standard. It includes:
- Batch number
- expiry date
- Serial number
Some rules and suggestions have been published for this. The serial number should contain only 20 alpha-numeric characters and should be randomized in the best case. However, it is recommended to limit the code to numbers. If letters are used, the Australian authority advises, in the interest of readability, to avoid similar characters such as a mix of upper- and lower-case letters and special characters. The TGO 106 considers 2D DataMatrix and/or 2D barcodes as machine-readable codes. Aggregation is recommended but not required.
Exceptions to TGO 106
There are also some exceptions for serialization in the regulation. Drugs affected by the National Blood Agreement are excluded from TGO 106. This also applies to special circumstances including clinical trials, supply difficulties, and drug distribution in individual cases. Pharmaceuticals intended for export or import with subsequent exportas well as medicine given to the immediate family of and for importers themselves, are not covered by TGO 106.[Disclaimer]
This information is only one possible interpretation of the regulations. They are also in a constant state of change, so the information in this article may be incomplete or out of date. The above article is expressly no legal advice. Please refer to the official documents for information before making any business decisions. (Status of information: January 2023)